Final Results of the Randomised Phase 2 Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer (ARNEO)

What Was Tested

Researchers studied Degarelix in this randomized controlled trial publication.

High-risk prostate cancer (PCa) carries a substantial risk of recurrence and progression after radical prostatectomy (RP).

This study aims to assess the oncological and quality-of-life outcomes of neoadjuvant DEG + APA compared with DEG + PBO.

Who Took Part

The age groups tagged for this paper are middle-aged adults and older adults, men only.

ARNEO was a double-blind, randomised, PBO-controlled phase 2 trial investigating neoadjuvant DEG + APA in high-risk PCa patients eligible for RP.

Patients received 3 mo of neoadjuvant DEG + APA or DEG + PBO.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

As a double-blind Degarelix study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Degarelix could be set against what happens without it.

No adjuvant or salvage therapy was given unless biochemical recurrence (BCR) occurred.

Quality-of-life data were collected at predefined time points.

The prespecified secondary endpoints included a between-arm comparison of testosterone recovery (testosterone ≥150 ng/ml), BCR within 3 yr (prostate-specific antigen ≥0.2 ng/ml), BCR-free survival (BCR-FS), and quality of life according to treatment allocation.

Quality of life was assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, International Index of Erectile Function-5 items, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 questionnaires.

Exploratory analyses included metastasis-free survival (MFS) and the relation of outcomes according to pathological outcomes.

What Was Measured

Topics PubMed links to this paper include Prostatic Neoplasms, Prostatectomy, Neoadjuvant Therapy, Oligopeptides, Quality of Life, Antineoplastic Combined Chemotherapy Protocols and Thiohydantoins.

The authors tagged it with the keywords High risk, Prostate cancer and Radical prostatectomy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Degarelix.

Results are reported in around 10 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2026 (European urology oncology), a journal based in Netherlands.

More context: the Degarelix compound page, all human trials.